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FW: Seeking CTCAE domain experts from the clinical research community

From: Pathak, Jyotishman, Ph.D. <Pathak.Jyotishman@mayo.edu>
Date: Tue, 15 Jul 2008 20:03:46 -0500
Message-Id: <3E5ED3BF97EA9E43B069AB536CA2238125DA88@msgebe31.mfad.mfroot.org>
To: <public-hcls-coi@w3.org>
FYI -- this might of interest to some of us.
- Jyoti


From: CTSA Informatics Group [mailto:CTSAINFORMATICS@LIST.NIH.GOV] On Behalf Of Collier, Elaine (NIH/NCRR) [E]
Sent: Tuesday, July 15, 2008 7:23 PM
Subject: Seeking CTCAE domain experts from the clinical research community

Dear CTSA PIs, CTSA PCIR Work group, CTSA Informatics experts, and CTSA Administrators,


Please forward to clinical researchers, trialists, terminologists, and others in your communities who might be willing to participate in this effort to revise the CTC grading of adverse events, particularly those with experience using the CTC.  As you know this grading system has been used by communities outside of Cancer, including AIDs and rare disease clinical research networks.  Participation by those with expertise in clinical research broadly will be helpful for assuring a grading system appropriate for adverse events in all organ systems - many of which may also occur in other disease trials/studies. 


Please have interested individuals contact John directly. 






The caBIG Vocabularies and Common Data Elements (vCDE) Workspace is looking for caBIG participants with experience in conducting clinical trials, and with an interest in adverse event reporting, to help to revise the Common Terminology Criteria for Adverse Events (CTCAE). 


CTCAE is an NCI terminology that is used for adverse event (AE) reporting. CTCAE v3.0 is used to report AEs occurring in NCI sponsored clinical trials. The vCDE Workspace and NCI's Cancer Therapy Evaluation Program (CTEP) are conducting a project to revise the (CTCAE) terminology, in conjunction with the FDA and pharmaceutical manufacturers. 


Goals of the project are:

-- to harmonize CTCAE with MedDRA,

-- to revise and extend CTCAE AEs and severity indicators,

-- to establish formal, ongoing governance for future maintenance of CTCAE,

-- to produce CTCAE as a machine interpretable terminology conforming to caBIG standards, and

-- to make CTCAE better meet the needs of trialists.


We are looking for clinician subject matter experts to join one of ten or so Work Groups. Each Work Group will review and revise as needed the AE terms and associated severity indicators for a collection of perhaps a hundred adverse events that are related to each other (an example might be AEs from the cardiac general/cardiac arrhythmia/vascular categories).  The Work Groups will be small (3-5 experts each), collaborative, and ideally will contain representation of the clinical trialist and clinical research reporting points of view. 


The project is beginning now and will run until spring 2009. Most of the work of the Work Groups will be via Wiki and teleconference. Support will be provided for one or two face to face meetings if needed. 


Please contact me if you are interested and/or would like more details.





John Speakman

Associate Director, Clinical Trials Products and Programs

Center for Biomedical Informatics and Information Technology

Office of the Director

National Cancer Institute

2115 East Jefferson Street, Suite 6000, Rockville MD 20892 USA

(Fedex and other couriers please use zip code 20852)

+1 301.451.8786

john.speakman@nih.gov <mailto:john.speakman@nih.gov> 

Received on Wednesday, 16 July 2008 01:04:30 UTC

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